Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Double Blade Scalpel (DBS) and De-epithelized (DE) SCTG Associated With Coronally Advanced Flap (CAF): a Split-mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Percentage of root coverage based on Recession depth at baseline and after 6 months
研究概览
简要总结
This split-mouth randomized clinical trial compared two different types of subepithelial connective tissue grafts (SCTG) considering clinical parameters and patient-centered outcomes in patients with bilateral RT 1 multiple gingival recessions after 6 months postoperatively. 21 patients with 84 sites were surgically treated with coronally advanced flap (CAF) associated with SCTG harvested by: double blade scalpel (DBS) and de-epithelized (DE) SCTG. Periodontal clinical parameters and aesthetics were evaluated by a calibrated periodontist at baseline and after 6 months. Patient-centered outcomes related to pain/discomfort and aesthetics were assessed with Visual Analogue Scale (VAS) after 7 days and 6 months, respectively. Gingival blood flows were analyzed by Laser Doppler flowmetry (FLD) at baseline and 2, 7 and 14 days postoperatively.
详细描述
Clinical parameters and patient-centered outcomes
Periodontal clinical examination was performed by a blind and calibrated examiner (intra-class correlation coefficient = 0.72) using a North Carolina periodontal probe (PCPUNC-Hu-Friedy®). Periodontal parameters were evaluated at baseline and after 6 months postoperatively and included:
- Recession depth (RD) - Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth;
- Recession width (RW) - Distance between interproximal gingival margins of GR with periodontal probe positioned at CEJ;
- Probing depth (PD) - Distance in millimeters from the gingival margin to the bottom of the gingival sulcus;
- Clinical attachment level (CAL) - Distance in millimeters from the CEJ to the bottom of the gingival sulcus;
- Keratinized tissue width (KTW) - Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth;
- Keratinized tissue thickness (KTT): determined 1.5 mm apically to gingival margin with an anesthesia needle and a rubber endodontic stop inserted perpendicularly into the soft tissue and measured with a digital caliper.
The index proposed by Zucchelli & DeSanctis (2000) was used to calculate percentage of root coverage (%RC), as follows:
RRC=(100.(RD baseline-RD 6 months))/(RD baseline) Patient centered outcomes and professional assessment were evaluated with visual analog scales (VAS). VAS was administered verbally to the patients to assess aesthetics and postoperative pain/discomfort. Patients were asked to make a mark in a scale between 0 (not satisfied or extreme pain) and 10 (very satisfied or no pain). Pain and discomfort were recorded after 7 days and patient´s aesthetic evaluation after 6 months. An experienced periodontist (intra-class correlation coefficient = 0.95) evaluated aesthetic outcome after 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systemically healthy patients between 18 and 70 years
- •clinical diagnosis of bilateral multiple gingival recessions, recession type (RT) 1 (Cairo et al. 2011) with at least one gingival recession ≥ 2 mm on each side, including canines and premolars.
排除标准
- •abnormal teeth position
- •smokers, pregnant or nursing women
- •parafunctional habits
- •plaque and bleeding indexes (Ainamo & Bay, 1975) above 20%
- •previous periodontal surgeries on selected sites.
结局指标
主要结局
Percentage of root coverage based on Recession depth at baseline and after 6 months
时间窗: 6 months
Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth
次要结局
- Variation on: Recession width (RW) comparing baseline measurements to 6 months.(6 months)
- Pain and discomfort- Patient centered outcomes(7 days)
- Esthetics-Periodontist evaluation(6 months)
- Variation on: Keratinized tissue thickness (KTT) comparing baseline measurements to 6 months.(6 months)
- Variation on: Keratinized tissue width (KTW) comparing baseline measurements to 6 months.(6 months)
- Esthetics-Patient centered outcomes(6 months)
- Variation on: Probing depth (PD) comparing baseline measurements to 6 months.(6 months)
- Variation on: Clinical attachment level (CAL) comparing baseline measurements to 6 months.(6 months)
研究者
Mariana Ragghianti Zangrando
Assistent Professor
University of Sao Paulo
